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    <tradeName>LL combo stopper - white NO PVC</tradeName>
    <deviceName>Combi zátka LL - bílá NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0799</emdnCode>
    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z676006</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:16.844Z</lastUpdated>
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    <udiDi>08593540513274</udiDi>
    <basicUdiDi>B-08593540513274</basicUdiDi>
    <tradeName>LL combo stopper - blue NO PVC</tradeName>
    <deviceName>Combi zátka LL - modrá NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:14.448Z</lastUpdated>
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    <udiDi>08593540513267</udiDi>
    <basicUdiDi>B-08593540513267</basicUdiDi>
    <tradeName>LL combo stopper - red NO PVC</tradeName>
    <deviceName>Combi zátka LL - červená NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0799</emdnCode>
    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z676004</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:13.172Z</lastUpdated>
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    <udiDi>08593540513021</udiDi>
    <basicUdiDi>B-08593540513021</basicUdiDi>
    <tradeName>08593540513021</tradeName>
    <deviceName>GAMAPLUS 1,8 x 1800 LLK</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606304-01ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:12.265Z</lastUpdated>
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    <udiDi>08593540512994</udiDi>
    <basicUdiDi>B-08593540512994</basicUdiDi>
    <tradeName>08593540512994</tradeName>
    <deviceName>GAMAPLUS 1,8 x 450 LLK</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606301-01ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:09.633Z</lastUpdated>
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    <udiDi>08593540512918</udiDi>
    <basicUdiDi>B-08593540512918</basicUdiDi>
    <tradeName>Urodynamická súprava malá USM-S</tradeName>
    <deviceName>Urodynamická souprava malá USM-S</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0599</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606481-03ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:07.266Z</lastUpdated>
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    <udiDi>08593540512857</udiDi>
    <basicUdiDi>B-08593540512857</basicUdiDi>
    <tradeName>Cievka pre výživu novorodenca CV-01</tradeName>
    <deviceName>Cévka pro výživu novorozence CV-01</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V028002</emdnCode>
    <emdnDescription>NEONATOLOGY CARE KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646957-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:05.640Z</lastUpdated>
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    <udiDi>08593540512604</udiDi>
    <basicUdiDi>B-08593540512604</basicUdiDi>
    <tradeName>Reverzačný set</tradeName>
    <deviceName>Reverzační set</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010199</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606136-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:04.844Z</lastUpdated>
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    <udiDi>08593540512581</udiDi>
    <basicUdiDi>B-08593540512581</basicUdiDi>
    <tradeName>IRIGAČNÝ SET</tradeName>
    <deviceName>Irigační set</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606135-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:03.236Z</lastUpdated>
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    <udiDi>08593540512437</udiDi>
    <basicUdiDi>B-08593540512437</basicUdiDi>
    <tradeName>Spojovacia hadička s bezihlovým vstupom</tradeName>
    <deviceName>Spojovací hadička s bezjehlovým vstupem</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V686424-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:00.837Z</lastUpdated>
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    <udiDi>08593540512567</udiDi>
    <basicUdiDi>B-08593540512567</basicUdiDi>
    <tradeName>Cievka pre novorodenca s nízkou pôrodnou hmotnosťou CN-01 100 cm</tradeName>
    <deviceName>Cévka pro novorozence s nízkou porodní hmotností CN-01 100 cm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V028002</emdnCode>
    <emdnDescription>NEONATOLOGY CARE KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V686417-01ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:59.230Z</lastUpdated>
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    <udiDi>08593540512468</udiDi>
    <basicUdiDi>B-08593540512468</basicUdiDi>
    <tradeName>08593540512468</tradeName>
    <deviceName>HDF on-line set</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020180</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V686435-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:58.525Z</lastUpdated>
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    <udiDi>08593540512406</udiDi>
    <basicUdiDi>B-08593540512406</basicUdiDi>
    <tradeName>Predlžovacia hadička PVC, 50 cm pre svetlocitlivé lieky</tradeName>
    <deviceName>Prodlužovací hadička PVC, 50 cm pro světlocitlivé léky</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V686423-02ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:56.024Z</lastUpdated>
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    <udiDi>08593540512376</udiDi>
    <basicUdiDi>B-08593540512376</basicUdiDi>
    <tradeName>Predlžovacia hadička PVC, 200 cm pre svetlocitlivé lieky</tradeName>
    <deviceName>Prodlužovací hadička PVC, 200 cm pro světlocitlivé léky</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V686423-01ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:39.900Z</lastUpdated>
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    <udiDi>08593540512345</udiDi>
    <basicUdiDi>B-08593540512345</basicUdiDi>
    <tradeName>Predlžovacia hadička PVC, 150 cm pre svetlocitlivé lieky</tradeName>
    <deviceName>Prodlužovací hadička PVC, 150 cm pro světlocitlivé léky</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V686423-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:39.101Z</lastUpdated>
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    <udiDi>08593540512314</udiDi>
    <basicUdiDi>B-08593540512314</basicUdiDi>
    <tradeName>Kyreta aspiračná 9mm x 200mm</tradeName>
    <deviceName>Kyreta aspirační 9mm x 200mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089010</emdnCode>
    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646683-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:38.299Z</lastUpdated>
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    <basicUdiDi>B-08593540512284</basicUdiDi>
    <tradeName>Kyreta aspiračná 8mm x 200mm</tradeName>
    <deviceName>Kyreta aspirační 8mm x 200mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089010</emdnCode>
    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646682-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:37.499Z</lastUpdated>
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    <basicUdiDi>B-08593540512253</basicUdiDi>
    <tradeName>Kyreta aspiračná 7mm x 200mm</tradeName>
    <deviceName>Kyreta aspirační 7mm x 200mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646681-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:33.500Z</lastUpdated>
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    <tradeName>Kyreta aspiračná 6mm x 200mm</tradeName>
    <deviceName>Kyreta aspirační 6mm x 200mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>U089010</emdnCode>
    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646680-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:32.698Z</lastUpdated>
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    <basicUdiDi>B-08593540512185</basicUdiDi>
    <tradeName>Prevodová súprava PS</tradeName>
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    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040202</emdnCode>
    <emdnDescription>OCULAR IRRIGATION KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606386-02ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:41:31.899Z</lastUpdated>
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